Safety and Efficacy of YHD001 in Asthma | NCT01424124

Studies
Safety and Efficacy of YHD001 in Asthma

NCT01424124

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

Jul 10, 2014Estimated

Enrollment

56Actual

Phase

Phase 2

Conditions

Asthma

Interventions

YHD001 dose level 1
YHD001 dose level 2
Singulair
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Aug 24, 2011

First Submission Date that Met QC Criteria

Aug 25, 2011

First Posted Date

Aug 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2014

Last Update Posted Date

Jul 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.

Detailed Description

Singulair: Montelukast sodium (leukotriene modulator)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
YHD001 dose level 1	Experimental	Drug: YHD001 dose level 1
YHD001 dose level 2	Experimental	Drug: YHD001 dose level 2
Singulair	Active Comparator	Drug: Singulair
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YHD001 dose level 1	Drug	Tablet, three times daily / 8 weeks	YHD001 dose level 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of FEV1 at week 4	FEV1: Forced Expiratory Volume In One Second	Baseline, week 4

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of FEV1 at week 8		Baseline, week 8
Change from baseline of PEFR at week 8	PEFR: Peak Expiratory Flow Rate	Baseline, week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed written informed consent
Acceptable medical history, physical exam,laboratory tests and EKG, during screening
Nonsmoking (for longer than 1 year) patients with asthma
Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)

Exclusion Criteria:

History of any clinically significant disease
History of drug/chemical/alcohol abuse
Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided